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. 2021 May 28;18(5):352–361. doi: 10.11909/j.issn.1671-5411.2021.05.006

Table 3. Ongoing trials studying the anticoagulation treatment in patients with AF and HF, who underwent TAVI.

Study Name Duration Type Expected population (participants) AF patients Comparators Primary endpoint
1Described adverse event composite includes all-cause death, MI, ischemic stroke, systemic embolic events (SEE), valve thrombosis, and major bleeding per definition of the International Society on Thrombosis and Hemostasis.
2The composite of all-cause death, TIA/stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep venous thrombosis, systemic embolism, life-threatening, disabling or major bleeding, according to the Valve Academic Research Consortium definitions.
3Death from any cause, myocardial infarction, stroke all causes, valve thrombosis and hemorrhage ≥ 2 as defined by the VARC 2 (Valve Academic Research Consortium scale). AF: atrial fibrillation; MI: myocardial infarction; NA: not available; NOAC: non-vitamin K oral anticoagulants; RCT: randomized-control trial; SEE: systemic embolic events; TAVI: transcatheter aortic valve implantation.
ENVISAGE-TAVI AF[76] 2017−2021 RCT 1,400 All Edoxaban vs. Warfarin Number of participants experiencing the described adverse event composite within 36 months.1
ATLANTIS[77] 2016−2020 RCT 1509 Stratum 1 (patients requiring lifetime OAC) Apixaban vs. Warfarin Composite Primary Endpoint in 12 months.2
AVATAR 2017−2020 RCT 170 NA NOAC vs. NOAC + aspirin Composite Primary Endpoint in 12 months.3